Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 4/17/2018 |
| Start Date: | September 2016 |
| End Date: | December 2019 |
| Contact: | Vanderbilt-Ingram Service for Timely Access |
| Phone: | 800-811-8480 |
Assessing Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors
This research trial studies skin/soft tissue elasticity in head and neck cancer survivors
with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck
cancer which may lead to skin tightness, pain, and body image issues. Early detection of
lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave
elastography is a technique that provides a quantitative measure of stiffness using a push
pulse to generate shear waves within the tissues. Conventional imaging techniques are then
used to monitor the shear waves generated through the tissue to calculate the shear wave
speed. Shear wave elastography may help obtain an early and accurate measurement of tissue
elasticity in head and neck cancer survivors.
with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck
cancer which may lead to skin tightness, pain, and body image issues. Early detection of
lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave
elastography is a technique that provides a quantitative measure of stiffness using a push
pulse to generate shear waves within the tissues. Conventional imaging techniques are then
used to monitor the shear waves generated through the tissue to calculate the shear wave
speed. Shear wave elastography may help obtain an early and accurate measurement of tissue
elasticity in head and neck cancer survivors.
PRIMARY OBJECTIVES:
I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at
the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis
(LEF).
II. To explore the correlation between elasticity of skin/soft tissues and the following: 1)
symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck
(LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the
Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head
and Neck LEF Grading Criteria.
OUTLINE:
Participants will be evaluated for LEF status using the Head and Neck External Lymphedema -
Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of
Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and
Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and
Neck (LSIDS-H&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes.
Participants' cancer disease and treatment information will be gathered from their medical
records.
I. To obtain pilot data of the elasticity of skin/soft tissues using shear wave elasticity at
the defined anatomical sites in head and neck cancer survivors with lymphedema and fibrosis
(LEF).
II. To explore the correlation between elasticity of skin/soft tissues and the following: 1)
symptoms as measured by the Lymphedema Symptom Intensity and Distress Survey-Head and Neck
(LSIDS-HN); 2) functional impact as measured by Cervical Range of Motion Device and the
Vanderbilt Head and Neck Symptom Survey; and 3) physical exam findings as measured by Head
and Neck LEF Grading Criteria.
OUTLINE:
Participants will be evaluated for LEF status using the Head and Neck External Lymphedema -
Fibrosis (HN-LEF) Grading Criteria and neck range of motion using the Cervical Range of
Motion Device. Participants also complete study questionnaires, including Vanderbilt Head and
Neck Symptom Survey (VHNSS) and Lymphedema Symptom Intensity and Distress Survey - Head and
Neck (LSIDS-H&N). Participants undergo ultrasound shear wave elastography over 20-25 minutes.
Participants' cancer disease and treatment information will be gathered from their medical
records.
Inclusion Criteria:
- Histologically confirmed cancer involving the head and neck
- Completed all therapy
- No evidence of cancer (NED)
- Ability to understand English in order to complete questionnaires
- Able to provide informed consent
Exclusion Criteria:
- Have medical record documentation of significant cognitive impairment that would
preclude the ability to provide informed consent
- Are unwilling to undergo the study assessment
- Have recurrent and/or metastatic cancer
We found this trial at
1
site
Nashville, Tennessee 37232
Principal Investigator: Kenneth J. Niermann
Phone: 615-322-2555
Click here to add this to my saved trials
